Neovasc Announces FDA Approval of Planned COSIRA II Sub-studies and Single Arm Registry to Allow Inclusion of Additional Specified Patient Populations

Provided By Globe Newswire

Last update: Jul 26, 2022

VANCOUVER and MINNEAPOLIS, July 26, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today announced the United States Food and Drug Administration (“FDA”) has approved a protocol supplement to the COSIRA-II Investigational Device Exemption (“IDE”) Trial. The approval expands the number of patients eligible for treatment in the trial and adds two previously planned imaging sub-studies designed to provide insights into the safety and mechanism of action of the Neovasc Reducer™ (“Reducer”). The timing of the approval is ahead of the Company’s internal target and will allow for additional patients to be treated.